Unipack

Basic Information

• Brand Name: Unipack
• Primary DI: D784URS551121
• Version / Model: URS-55112
• Catalog Number: URS-55112
• Company Name: UNIPACK MEDICAL CORPORATION
• Labeler DUNS: 018319397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2023-12-13
• Public Version Status: Update
• Public Device Record Key: 6ce1e712-94b5-438a-a7a8-4c44c3b5d25d

Device Description

Utility Syringes Curved 12cc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58894	Dental impression material syringe, single-use	A non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D784URS551125	HIBCC	Case	10	In Commercial Distribution
Primary	D784URS551121	HIBCC
Unit of Use	D784URS551120	HIBCC

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]